Merger and Financial Condition - The Company has entered into a Merger Agreement with SEP Acquisition Corp., which will result in the issuance of 7,793,000 shares of Class A Common Stock of SEPA to holders of Company common stock and other securities[17]. - Approximately 95% of outstanding warrants and 100% of convertible notes have committed to exchange for an aggregate of 1,217,222,186 shares and 219,841,980 shares of common stock, respectively, prior to the Closing[18]. - The Merger Agreement includes a Minimum Cash Condition of at least $12,000,000, which must be satisfied for the Business Combination to be consummated[93]. - SEPA Stockholders elected to redeem 495,067 shares of Class A Common Stock, necessitating PIPE Investment to satisfy the Minimum Cash Condition[94]. - As of the filing date, no commitments have been made for the proposed financing from the PIPE Investment, creating uncertainty regarding the amount raised[95]. - The company is required to raise additional funds to finance operations and remain a going concern, indicating substantial doubt about its ability to continue for at least twelve months from the filing date[111]. - The company has a history of losses, raising concerns about the Combined Company's ability to achieve or maintain profitability[106]. - The company incurred a net loss of $25.8 million and $10.3 million for the years ended December 31, 2023, and 2022, respectively[112]. - The operating loss was reduced by 94% to $0.5 million for the year ended December 31, 2023, compared to $9.0 million in 2022[209]. - The net loss for 2023 was $25.8 million, or ($0.03) per share, compared to a net loss of $10.3 million, or ($0.02) per share, in 2022[209]. - Management aims to secure additional capital in early 2024 primarily through the merger, but current private placements restrict the ability to incur new debt[116][123]. Product Development and Technology - The dermaPACE system has received FDA approval and is aimed at treating diabetic foot ulcers, which are a leading cause of hospitalization among diabetic patients, leading to billions in healthcare expenditures annually[24]. - The UltraMIST system is FDA approved for treating various wound types, including diabetic foot ulcers and pressure ulcers, by promoting healing below the skin surface[21]. - The PACE technology is designed to activate healing through acoustic pressure shockwaves, promoting angiogenesis and tissue regeneration[22]. - The Company is focused on the commercialization of its patented, non-invasive medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures[27]. - The Company has established a network of scientific advisors to assist in clinical and pre-clinical study design and product development[28]. - The Company has a manufacturing supply agreement with Minnetronix Medical for the generator and treatment wand components, ensuring compliance with quality standards[33]. - The Company’s facility in Eden Prairie, MN is FDA registered and ISO 13485:2016 certified, providing office, product development, quality control, and warehouse space[36]. - The company entered into a license agreement with HealthTronics in August 2005, acquiring certain assets and intellectual property related to orthopedic and other medical conditions[40]. - In August 2020, the company acquired all assets related to the MIST Therapy System and UltraMIST System from Celularity, including intellectual property and trademarks[44]. - The company has a perpetual, non-exclusive and royalty-free license to nine issued foreign patents, with some patents expiring as late as 2038[43][49]. - The company holds a diverse patent portfolio, including shockwave devices and ultrasound technologies, with expiration dates extending into the 2040s[48][52]. Regulatory Compliance and Risks - Medical devices require FDA authorization prior to marketing, either through a 510(k) clearance or a PMA approval, with 510(k) submissions needing to demonstrate substantial equivalence to legally marketed devices[65]. - The company must comply with extensive post-approval regulations, including quality systems regulation and specific controls based on device classification[68]. - The company is subject to various international regulations and product registration requirements, which may differ significantly from FDA requirements[75]. - The company is registered as a Small Business Manufacturer with the FDA, which subjects it to reduced fees; however, exceeding a certain revenue threshold may result in losing this status[67]. - The company is subject to extensive governmental regulation, including FDA approval, which could affect the commercialization of its products[106]. - The company faces significant transaction and transition costs related to the Business Combination, which may impact future financial performance[103]. - The company is subject to periodic reviews and audits from governmental and private payors, which could result in significant costs and adverse effects on business operations[157]. - Regulatory compliance is extensive, with potential consequences including fines, product recalls, and operational restrictions[139][140]. - The company anticipates increased operational costs due to compliance with HIPAA regulations as it expands its business[155][156]. - The company may face increased restrictions on reimbursement for its products, impacting market acceptance and future revenues[146]. - Non-compliance with the Federal Anti-Kickback Statute and False Claims Act could lead to severe penalties and exclusion from federal healthcare programs[151][152]. Competition and Market Environment - The advanced wound care market is competitive, with major players including Acelity and Organogenesis, but the company believes its PACE technology offers superior value[58]. - The company faces competition from various companies in the extracorporeal shockwave device market, but believes its PACE systems have a competitive advantage[59]. - The medical device industry is highly competitive, with significant risks from established companies with greater resources and rapid technological changes[126]. - The company may seek to expand operations through acquisitions, which would likely increase capital requirements[125]. - Less than 5% of the company's revenue comes from international sources, with no current plans for significant international expansion[137]. Financial Performance and Stock Information - The company achieved a revenue growth of 22%, reaching $20.4 million for the year ended December 31, 2023, compared to $16.7 million in 2022[208]. - Gross margins decreased to 70% in 2023 from 74% in 2022[208]. - The company has not paid dividends in 2023 or 2022 and does not anticipate paying any in the foreseeable future[205]. - As of December 31, 2023, there were 1,140,559,527 shares of common stock outstanding[204]. - The stock price is volatile, influenced by operating results, financing ability, and market fluctuations[178]. - There is currently a limited trading market for the company's common stock, affecting liquidity[181]. Internal Controls and Cybersecurity - The Company has identified material weaknesses in internal controls over financial reporting, which could lead to misstatements in financial statements if not remediated[119][120]. - The company has experienced cybersecurity breaches, including email spoofing, despite investments in data protection[135]. - The company has not experienced any material cybersecurity breaches, but acknowledges potential future risks[196]. - The company relies heavily on information technology systems, facing risks from cybersecurity breaches and data leakage[134]. Supply Chain and Operational Risks - The company faces supply chain risks, as many product components are sourced from single suppliers, which could disrupt production if issues arise[127][128]. - There are potential liabilities from product use that could result in financial loss, with current insurance coverage possibly insufficient to cover claims[133]. - The company may incur significant costs due to compliance with federal, state, and local environmental laws and regulations[159]. - The company faces potential liabilities related to the use of hazardous materials in its operations, which could exceed its resources[159].

Financial Performance - Total revenue for Q3 2023 was $4,953,000, representing a 19% increase from $4,166,000 in Q3 2022[18] - Gross margin improved to $3,541,000 in Q3 2023, up from $3,009,000 in Q3 2022, indicating a stronger operational efficiency[18] - Operating loss decreased to $531,000 in Q3 2023 compared to $2,485,000 in Q3 2022, reflecting improved cost management[18] - Net loss for Q3 2023 was $23,700,000, significantly higher than the $1,139,000 loss in Q3 2022, primarily due to increased interest expenses and changes in fair value of derivative liabilities[18] - For the nine months ended September 30, 2023, the company reported a net loss of $44,042,000, compared to a net loss of $4,596,000 for the same period in 2022[27] - Net cash used in operating activities was $3,253,000, a significant improvement from $13,176,000 in the prior year[27] - The company reported a basic and diluted loss per share of $0.03 for Q3 2023, compared to a loss of $0.00 in Q3 2022[18] - EBITDA for the three months ended September 30, 2023, was $(19.589) million, compared to $2.917 million in the same period of 2022[96] - Adjusted EBITDA for the three months ended September 30, 2023, was $(0.264) million, compared to $(2.249) million in the same period of 2022[96] Assets and Liabilities - Total current assets increased to $7,394,000 as of September 30, 2023, compared to $6,620,000 at the end of 2022, driven by higher inventory levels[14] - Total liabilities rose to $86,296,000 as of September 30, 2023, up from $60,883,000 at the end of 2022, largely due to increased senior secured debt[14] - The company’s accumulated deficit increased to $238,284,000 as of September 30, 2023, compared to $194,242,000 at the end of 2022[16] - Cash balance decreased to $1,095,000 as of September 30, 2023, down from $1,153,000 at the end of 2022, indicating liquidity challenges[14] Shareholder Information - The number of shares outstanding increased to 1,026,078,464 as of September 30, 2023, from 548,737,651 at the end of 2022, reflecting shares issued for debt settlement[21] - The merger agreement involves SEPA acquiring 100% of the company's issued and outstanding equity securities, with the company's stockholders expected to hold approximately 69-70% of the combined company[47] - The merger consideration will consist of 7,793,000 shares of Class A Common Stock, allocated pro rata based on ownership after the conversion of outstanding convertible notes[48] Merger and Capital Resources - The company expects to devote substantial resources for the commercialization of UltraMIST and PACE systems, which will require additional capital resources[34] - The company plans to obtain additional capital primarily through closing a merger, which is expected to provide necessary funding[35] - The company has deferred $732,000 in merger costs until the closing of the merger[44] - Management plans to obtain additional capital primarily through the closure of the merger, which is expected to add approximately $12 million of additional capital[107] - The Merger Agreement includes a Minimum Cash Condition of $12 million, which must be satisfied for the Business Combination to be completed[130] Internal Controls and Compliance - The company has identified material weaknesses in its internal control over financial reporting as of September 30, 2023, which management is actively working to remediate[120] - The company is working with an external vendor to improve internal controls and ensure compliance with U.S. GAAP[121] - The company has not made any changes to its internal control over financial reporting that materially affect its operations during the quarter ended September 30, 2023[126] Risks and Uncertainties - The company faces risks related to the Business Combination, including conditions that may not be satisfied in a timely manner[129] - The company cannot assure that the shares of the Combined Company's Class A Common Stock will be approved for listing on Nasdaq following the Closing[137] - The Combined Company must maintain a minimum market capitalization of $50,000,000 and at least 300 public shareholders to continue listing on Nasdaq[138] - Significant transaction and transition costs are expected due to the Business Combination, including legal, accounting, and consulting fees, which will be paid by the Combined Company after closing[141] - Uncertainty surrounding the Business Combination may disrupt relationships with customers, suppliers, and business partners, potentially affecting future operations[139] - The Company is subject to contractual restrictions that may limit its ability to pursue business opportunities until the Business Combination is completed[140] - There is a risk that employees may experience uncertainty about their future roles, impacting the ability to retain and hire key personnel[143] Expenses and Financial Management - General and administrative expenses decreased by $0.8 million or 23% for the three months ended September 30, 2023, compared to the same period in 2022[101] - Selling and marketing expenses decreased by $0.6 million or 37% for the three months ended September 30, 2023, compared to the same period in 2022[102] - Other expense, net increased by $24.5 million to $23.2 million for the three months ended September 30, 2023, compared to the same period for 2022[105] - Cash provided by financing activities was $3.4 million for the nine months ended September 30, 2023, primarily due to new bridge notes payable and convertible lending activities[109]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 For the transition period from ________ to Commission File Number 000-52985 SANUWAVE Health, Inc. (Exact name of registrant as specified in its charter) Nevada 20-1176000 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 11495 Valley ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to. Commission File Number: 000-52985 SANUWAVE Health, Inc. (Exact Name of Registrant as Specified in Charter) Nevada 20-1176000 (State or Other Jurisdiction of Incorporation) ...